JP7257739B2 - レボノルゲストレルおよびエチニルエストラジオールのための経皮的薬物送達システム - Google Patents

レボノルゲストレルおよびエチニルエストラジオールのための経皮的薬物送達システム Download PDF

Info

Publication number
JP7257739B2
JP7257739B2 JP2017568250A JP2017568250A JP7257739B2 JP 7257739 B2 JP7257739 B2 JP 7257739B2 JP 2017568250 A JP2017568250 A JP 2017568250A JP 2017568250 A JP2017568250 A JP 2017568250A JP 7257739 B2 JP7257739 B2 JP 7257739B2
Authority
JP
Japan
Prior art keywords
drug delivery
delivery system
transdermal drug
levonorgestrel
polymer matrix
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
JP2017568250A
Other languages
English (en)
Japanese (ja)
Other versions
JP2018524348A5 (https=
JP2018524348A (ja
Inventor
ジョシュア クラコフスキー
ジュン リャオ
Original Assignee
ノーヴェン ファーマシューティカルズ インコーポレイテッド
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ノーヴェン ファーマシューティカルズ インコーポレイテッド filed Critical ノーヴェン ファーマシューティカルズ インコーポレイテッド
Publication of JP2018524348A publication Critical patent/JP2018524348A/ja
Publication of JP2018524348A5 publication Critical patent/JP2018524348A5/ja
Priority to JP2023005043A priority Critical patent/JP7625623B2/ja
Application granted granted Critical
Publication of JP7257739B2 publication Critical patent/JP7257739B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
    • A61K9/7061—Polyacrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/567—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in position 17 alpha, e.g. mestranol, norethandrolone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7084—Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/18—Feminine contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gynecology & Obstetrics (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
JP2017568250A 2015-07-02 2016-07-01 レボノルゲストレルおよびエチニルエストラジオールのための経皮的薬物送達システム Active JP7257739B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2023005043A JP7625623B2 (ja) 2015-07-02 2023-01-17 レボノルゲストレルおよびエチニルエストラジオールのための経皮的薬物送達システム

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562188175P 2015-07-02 2015-07-02
US62/188,175 2015-07-02
PCT/US2016/040670 WO2017004507A1 (en) 2015-07-02 2016-07-01 Transdermal drug delivery systems for levonorgestrel and ethinyl estradiol

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2023005043A Division JP7625623B2 (ja) 2015-07-02 2023-01-17 レボノルゲストレルおよびエチニルエストラジオールのための経皮的薬物送達システム

Publications (3)

Publication Number Publication Date
JP2018524348A JP2018524348A (ja) 2018-08-30
JP2018524348A5 JP2018524348A5 (https=) 2019-08-29
JP7257739B2 true JP7257739B2 (ja) 2023-04-14

Family

ID=56409730

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2017568250A Active JP7257739B2 (ja) 2015-07-02 2016-07-01 レボノルゲストレルおよびエチニルエストラジオールのための経皮的薬物送達システム
JP2023005043A Active JP7625623B2 (ja) 2015-07-02 2023-01-17 レボノルゲストレルおよびエチニルエストラジオールのための経皮的薬物送達システム

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2023005043A Active JP7625623B2 (ja) 2015-07-02 2023-01-17 レボノルゲストレルおよびエチニルエストラジオールのための経皮的薬物送達システム

Country Status (3)

Country Link
US (1) US20170000745A1 (https=)
JP (2) JP7257739B2 (https=)
WO (1) WO2017004507A1 (https=)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9314470B2 (en) 2012-12-28 2016-04-19 Noven Pharmaceuticals, Inc. Transdermal drug delivery systems for levonorgestrel and ethinyl estradiol

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010500992A (ja) 2006-08-17 2010-01-14 コア テク ソリューションズ，インク． アルツハイマー病の経皮的治療法及び経皮的治療システム
WO2014100599A1 (en) 2012-12-21 2014-06-26 Teikoku Pharma Usa, Inc. Compositions and methods for transdermal delivery of hormones and other medicinal agents
WO2014106014A1 (en) 2012-12-28 2014-07-03 Noven Pharmaceuticals, Inc Transdermal drug delivery systems for levonorgestrel and ethinyl estradiol

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5843368B2 (ja) 1980-10-30 1983-09-27 日東電工株式会社 消炎鎮痛貼付剤
US4591622A (en) 1984-10-29 1986-05-27 Dow Corning Corporation Silicone pressure-sensitive adhesive process and product thereof
US4585836A (en) 1984-10-29 1986-04-29 Dow Corning Corporation Silicone pressure-sensitive adhesive process and product with improved lap-shear stability-II
US4584355A (en) 1984-10-29 1986-04-22 Dow Corning Corporation Silicone pressure-sensitive adhesive process and product with improved lap-shear stability-I
US4655767A (en) 1984-10-29 1987-04-07 Dow Corning Corporation Transdermal drug delivery devices with amine-resistant silicone adhesives
US4994267A (en) 1988-03-04 1991-02-19 Noven Pharmaceuticals, Inc. Transdermal acrylic multipolymer drug delivery system
US5656286A (en) 1988-03-04 1997-08-12 Noven Pharmaceuticals, Inc. Solubility parameter based drug delivery system and method for altering drug saturation concentration
US5053227A (en) * 1989-03-22 1991-10-01 Cygnus Therapeutic Systems Skin permeation enhancer compositions, and methods and transdermal systems associated therewith
US4973468A (en) * 1989-03-22 1990-11-27 Cygnus Research Corporation Skin permeation enhancer compositions
US5252334A (en) 1989-09-08 1993-10-12 Cygnus Therapeutic Systems Solid matrix system for transdermal drug delivery
US6337086B1 (en) 1999-02-06 2002-01-08 Dow Corning Corporation Pressure sensitive adhesive compositions for transdermal drug delivery devices
US7045145B1 (en) 1999-11-24 2006-05-16 Agile Therapeutics, Inc. Transdermal contraceptive delivery system and process
US7384650B2 (en) 1999-11-24 2008-06-10 Agile Therapeutics, Inc. Skin permeation enhancement composition for transdermal hormone delivery system

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010500992A (ja) 2006-08-17 2010-01-14 コア テク ソリューションズ，インク． アルツハイマー病の経皮的治療法及び経皮的治療システム
WO2014100599A1 (en) 2012-12-21 2014-06-26 Teikoku Pharma Usa, Inc. Compositions and methods for transdermal delivery of hormones and other medicinal agents
WO2014106014A1 (en) 2012-12-28 2014-07-03 Noven Pharmaceuticals, Inc Transdermal drug delivery systems for levonorgestrel and ethinyl estradiol

Also Published As

Publication number Publication date
US20170000745A1 (en) 2017-01-05
WO2017004507A1 (en) 2017-01-05
JP2023058501A (ja) 2023-04-25
JP2018524348A (ja) 2018-08-30
JP7625623B2 (ja) 2025-02-03

Similar Documents

Publication Publication Date Title
US9320742B2 (en) Transdermal testosterone device and delivery
US10987316B2 (en) Compositions and methods for transdermal delivery of tertiary amine drugs
JP6118774B2 (ja) エストロゲンの経皮デバイスおよび経皮送達
US10231977B2 (en) Transdermal drug delivery systems for levonorgestrel and ethinyl estradiol
US20140276479A1 (en) Transdermal drug delivery system with overlay
US8784877B2 (en) Transdermal levonorgestrel device and delivery
US20160184246A1 (en) Transdermal drug delivery systems for agomelatine
US20170112781A1 (en) Transdermal drug delivery systems with polyisobutylene face adhesive
JP7625623B2 (ja) レボノルゲストレルおよびエチニルエストラジオールのための経皮的薬物送達システム
US20180036319A1 (en) Transdermal drug delivery systems for norethindrone acetate
HK1155942B (en) Transdermal estradiol device and delivery

Legal Events

Date Code Title Description
A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20190628

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20190718

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20200706

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20201005

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20210208

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20210604

C60 Trial request (containing other claim documents, opposition documents)

Free format text: JAPANESE INTERMEDIATE CODE: C60

Effective date: 20210604

A911 Transfer to examiner for re-examination before appeal (zenchi)

Free format text: JAPANESE INTERMEDIATE CODE: A911

Effective date: 20210615

C21 Notice of transfer of a case for reconsideration by examiners before appeal proceedings

Free format text: JAPANESE INTERMEDIATE CODE: C21

Effective date: 20210617

A912 Re-examination (zenchi) completed and case transferred to appeal board

Free format text: JAPANESE INTERMEDIATE CODE: A912

Effective date: 20210730

C211 Notice of termination of reconsideration by examiners before appeal proceedings

Free format text: JAPANESE INTERMEDIATE CODE: C211

Effective date: 20210804

C22 Notice of designation (change) of administrative judge

Free format text: JAPANESE INTERMEDIATE CODE: C22

Effective date: 20220817

C13 Notice of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: C13

Effective date: 20221019

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20230117

C23 Notice of termination of proceedings

Free format text: JAPANESE INTERMEDIATE CODE: C23

Effective date: 20230206

C03 Trial/appeal decision taken

Free format text: JAPANESE INTERMEDIATE CODE: C03

Effective date: 20230306

C30A Notification sent

Free format text: JAPANESE INTERMEDIATE CODE: C3012

Effective date: 20230306

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20230404

R150 Certificate of patent or registration of utility model

Ref document number: 7257739

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250